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Lilly gets approval for earlier use of Jaypirca in CLL
Eli Lilly's fast-growing Jaypirca has won a new FDA approval as an earlier treatment for relapsed/refractory chronic lymphocytic leukaemia.
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FDA could hike user fees for ex-US drug programmes
FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.
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VuuAI and Amiculum partner to transform content engagement i...
Amiculum, a global health communications agency, has entered into an exciting strategic collaboration with VuuAI, a GenAI-driven content production automation plat
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Tracy Beth Hoeg will be fifth CDER head this year
Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.
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AZ uses a priority review voucher for baxdrostat filing
Seeking a lead over rival Mineralys, AstraZeneca is using a priority review voucher for its US filing for uncontrolled hypertension drug baxdrostat.
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